Kornimate/medical-research-clean huggingface dataset:
effectiveness of candesartan and telmisartan on morning hypertension in japanese obese patients

Conditions: Hypertension

Summary: to investigate the effects of candesartan and telmisartan on the home blood pressure, glucose and lipid-metabolism in the hypertensive patients with the accumulation of visceral fat by the newly developed tele-medicine system

a randomized, comparative study of the effects of candesartan and telmisartan on the home blood pressure, glucose and lipid metabolism in the hypertensive patients with the accumulation of visceral fat by the central registration system

Eligibility criteria:
inclusion criteria: * circumference at waist: male ≧85 cm, female ≧90 cm * hypertensive patient with untreated hypertension, and casual blood pressure of systole ≧140 mmhg, or diastole ≧90 mmhg * hypertensive patient with hypertension under treatment, and casual blood pressure of systole ≧130 mmhg, or diastole ≧85 mmhg exclusion criteria: * significant hypertensive patient with diastolic blood pressure ≧120 mmhg * malignant hypertensive patient * patient with a contraindication to the study drugs (hypersensitivity, significant hepatic diseases, pregnant woman) * patient with urinary protein (qualitative) ＋～＋＋ * patient with familial hyperlipidemia * other patients judged as ineligible for the study
an observational cohort study of the safety and efficacy of fibrinogen concentrate, human (fch) in subjects with congenital fibrinogen deficiency

Conditions: Congenital Fibrinogen Deficiency

Summary: this is a multicenter, non interventional, retrospective cohort study with a prospective, observational follow-up component to investigate the safety and efficacy of fch use in subjects with congenital fibrinogen deficiency. data will be collected on the safety and efficacy of fch as used for the treatment of acute bleeding episodes, routine prophylaxis and perioperative bleeding in these subjects. all subjects have received fch and may continue to receive fch at the discretion of the treating physician / primary investigator according to the standard of care at the participating study site.


Eligibility criteria:
inclusion criteria: * male or female subjects of any age with a diagnosis of congenital fibrinogen deficiency. * have received fch (haemocomplettan® p or riastap®) for treatment of bleeding, surgery or prophylaxis. exclusion criteria: none
near-infrared imaging with indocyanine green for detection of peritoneal metastases for gastric adenocarcinoma.

Conditions: Gastric Cancer; Gastric Adenocarcinoma; Peritoneal Carcinomatosis; Peritoneal Metastases

Summary: peritoneal disease at initial presentation for patients with gastric adenocarcinoma (ga) is frequent, with 15-31% of patients presenting with peritoneal metastases (pm) at surgical exploration. the prognosis of patients with pm is poor, overall survival (os) ranging from 8 to 13 months, reinforcing the importance of optimal patient selection before surgical management of ga. indocyanine green (icg) fluorescence imaging for intraoperative detection of pm has been described in recent literature as a useful tool in patients undergoing cytoreductive surgery (crs) with hyperthermic intraperitoneal chemotherapy (hipec) for peritoneal malignancies to increase the detection of pm during surgery. however, the role of icg for patients with ga, and its role during diagnosic laparoscopy (dl), remain unknown.

this is a multicentric, prospective study . patients will be referred to one of seven surgeons specialized in the surgical management of gastric cancer. patients will undergo dl, with intravenous (iv) injection of 0.25 mg/kg of free icg at the start of the surgery. dl will be first performed without fluorescence imaging in the standard fashion, with identification of potential pm. a first peritoneal cancer index (pci) score will be calculated. fluorescence imaging will then be performed, and correlation with previously identified lesions will be assessed and a second pci score (with icg) will be calculated. biopsies will be performed to confirm the metastatic status of the lesions. any suspicion for additional lesions visualized only under fluorescence imaging will be biopsied as well. peritoneal fluid cytology will be performed at the beginning of the surgery.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of gastric adenocarcinoma. * clinical stage ct2 or higher. * no evidence of metastatic disease on preoperative imaging. * patient fit for surgery (ecog 0 or 1). exclusion criteria: * indocyanine allergy. * gastric cancer subtype other than gastric adenocarcinoma. * unconfirmed diagnosis of gastric adenocarcinoma (unable to confirm diagnosis). * clinical stage ct1b or lower. * evidence of metastatic disease on preoperative imaging. * patient unfit for surgery (ecog 2 or more).

Keywords: diagnostic laparoscopy icg
shanghai beixinjing diabetic eyes study

Conditions: Diabetic Retinopathy; Visual Impairment; Diabetic Maculopathy

Summary: in industrialized nations diabetic retinopathy(dr) is the most frequent microvascular complication of type 2 diabetes mellitus and the leading cause of visual impairment and blindness in the working-age population. the well-accepted strategy for prevention and treatment of diabetic eye complications focused on confirmed diabetic retinopathy, diabetic macular edema, cataract, etc, and there was no definitive therapy for preclinical central visual acuity (cva) impairment, mainly because of its unknown pathogenesis. in our previous population-based study, the prevalence rate of early cva impairment was as high as 9.1%, and that obviously limits the effects of diabetic eye diseases prevention and early-stage treatment strategy. of note, the choriocapillaris is the only route for metabolic exchange in the retina within the foveal avascular zone, it was speculated that early cva impairment is related to diabetic choroidopathy (dc). recent research shows that the decreased macular choriocapillaris vessel density (mcvd) in diabetic eye ,which indicating early ischemia, is already present before diabetic macular edema can be observed; we have observed subfoveal choroidal thickness (sfct) decreased significantly in the early cva impairment patients. however, up til now, there was no epidemiology report on early cva impairment in chinese diabetes population. in the present study, we plan to conduct a 10-year perspective cohort observation of 2217 chinese type 2 diabetic residents without diabetic retinopathy, diabetic macular edema, cataract and other vision impairing diseases, trying to find out related physical and biochemical risk factors. the results will facilitate discriminating high risk groups of early cva impairment in diabetic patients. in the same time, a quantitative relationship between sfct change, mcvd change and cva change will be established. this study will demonstrate the role of dc in the occurrence of preclinical cva impairment, and provide important theoretic evidence of blocking agents which target on dc.


Eligibility criteria:
inclusion criteria: * ≥18 years old; * diabetes mellitus (dm) was defined as either blood hemoglobin a1c≥6.5%, use of diabetic medication or a physician diagnosis of diabetes. exclusion criteria: * none;

Keywords: type 2 diabetes mellitus diabetic retinopathy visual impairment diabetic choroidopathy
the application of the self care deficit nursing theory in adolescents with cystic fibrosis

Conditions: Cystic Fibrosis; Adolescence; Self-care

Summary: the present study evaluates the effect of nursing care based on the self-care deficit nursing theory on the knowledge and skills related to self-care among adolescents with cystic fibrosis.

this study included 30 adolescents who were equally divided into the intervention and control groups. the data were collected by using the sociodemographic data form and the self-care knowledge and skills evaluation forms for adolescents with cystic fibrosis. a total of seven home visits were conducted with the adolescents in the intervention group, during which individualized care plans were applied based on the self-care deficit nursing theory. the self-care needs of the adolescents in the control group were identified based on data collected during two home visits conducted at the onset of the study and after 4.5 months. as a result of the application of nursing interventions based on the self-care deficit nursing theory, a statistically significant increase was noted in the self-care knowledge and skills of the adolescents in the intervention group (p\<0.05). additionally, nursing interventions and nursing diagnosis decreased significantly over time in all adolescents in the intervention group (p\<0.05). orem's self-care deficit nursing theory was useful in enhancing the self-care knowledge and skills of adolescents with cystic fibrosis.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis determined by a positive sweat test and/or the presence of two cystic fibrosis mutations, * aged between 12 and 18 years * living in the same ankara exclusion criteria: * adolescents with mental health issues * adolescents with an atypical form of cystic fibrosis (characterized by an absence of symptoms and no medication requirement)

Keywords: cystic fibrosis adolescence self-care
port site pain following percutaneous externally-assembled laparoscopic donor nephrectomy

Conditions: Laparoscopic Donor Nephrectomy

Summary: a single-arm prospective internally-controlled study. patients will undergo percutaneous externally-assembled laparoscopic (peal) donor nephrectomy where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study

purpose: prior investigators have created methods to perform laparoscopic surgeries using smaller instruments and ports in an attempt to improve cosmesis and postoperative pain. however, these methods may be limited by the requirement for smaller instruments with decreased functionality or by the loss of instrument triangulation. we have previously published a study regarding the use of a new surgical paradigm (percutaneous externally assembled laparoscopy, or peal) in porcine and cadaveric models in order to allow laparoscopic surgery to take place with improved cosmesis and decreased pain while still allowing the use of larger instruments and maintaining instrument triangulation. we now seek to study the use of these instruments in the human patients undergoing laparoscopic urologic surgery. the procedures include: hundred subjects will be recruited for the study with an expected attrition rate of 10%. sample size has been minimized, but is necessary for statistical power and conclusions. subjects will be male and female 18 years or older, of all ethnicities, denominations or other social/economical variations. all participants will speak english fluently in order for consent to be performed properly. baseline pain score will be calculated through a questionnaire in at the urology clinic. this is a single-arm prospective internally-controlled study. patients will undergo percutaneous externally-assembled laparoscopic urologic surgery where one or more 3 mm instruments are added or substituted for conventional 5 or 12 mm trocars. multiple outcome measures (endpoints) will be measured including time to first opioid use, total inpatient opioid dosage, patient ranking of painfulness of each port site, duration of ileus, time to ambulation, length of hospital stay, presence of any intraoperative or postoperative complications, operating time, estimated blood loss, and other routine parameters collected in a prospective surgical study.

Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic donor nephrectomy exclusion criteria: * patients unwilling to participate in the study * patients unfit for laparoscopic surgery

Keywords: minimally invasive surgical procedures transplant donors
eliquis (vte treatment and prevention of recurrent vte) rpms

Conditions: Venous Thromboembolism

Summary: to assess the real-world safety/effectiveness of eliquis in korean venous thromboembolism (vte) patients and patient characteristics that are associated with bleeding among patients taking eliquis. to identify factors that might be associated with the safety and effectiveness profile in korean vte patients.


Eligibility criteria:
inclusion criteria: * adult (≥19 years of age) patients who are initiating treatment with eliquis for the treatment of vte or prevention of recurrent vte for the first time in accordance with the korean package insert will be enrolled in the study exclusion criteria: * patients with prior treatment with eliquis before enrollment in this study * patients receiving eliquis treatment for an indication not approved indication in korea * patients meeting any of the following criteria will not be included in the study: i) hypersensitivity to the active substance or to any of the excipients ii) clinically significant active bleeding iii) hepatic disease associated with coagulopathy and clinically relevant bleeding risk iv) patients with increased bleeding risk due to such as following diseases: 1. recent gastrointestinal ulceration history 2. recent intracranial or intracerebral haemorrhage history 3. intraspinal or intracerebral vascular abnormalities 4. recent brain, spinal or ophthalmic surgery history 5. recent brain or spinal injury 6. known or suspected oesophageal varices 7. arteriovenous malformations 8. vascular aneurysms 9. patients with malignant neoplasms at high risk of bleeding * concomitant treatment with any other anticoagulant agent: i) unfractionated heparin (ufh) ii) low molecular weight heparins (enoxaparin, dalteparin, etc) iii) heparin derivatives (fondaparinux, etc) iv) oral anticoagulants (warfarin, rivaroxaban, dabigatran, etc) except under the circumstances of switching therapy to or from apixaban or when ufh is given at doses necessary to maintain a patent central venous or arterial catheter * patients with rare hereditary problems of galactose intolerance, the lapp lactose deficiency or glucose-galactose malabsorption

Keywords: treatment tx prevent
study on the antiviral therapy and immune reconstitution of chinese hiv/aids patients

Conditions: Acquired Immune Deficiency Syndrome; HIV Infections

Summary: this study will recruit 520 treatment-naive and 150 treatment-experienced patients to take the first line or second line of antiviral therapy. this study aims to set up a well-trained clinical and laboratory team in china, to explore the effects and side-effects of the first-line and the second line of arv treatment in chinese hiv/aids adult patients, to investigate the side-effects of arv drugs, such as hepatotoxicity, lipoatrophy, cardiovascular influence, to explore the pharmacokinetics/pharmacodynamics (pk/pd) of chinese generic arv regiments and effective drug concentrations and to explore primary and secondary drug resistance in china and the immune reconstitution characters of long term arv in chinese adult aids patients. this study might provide more practical and optimizing prove for the treatment guideline for resource limited areas.

three arms will be studied in this research, 520 naive-treatment patients would be randomized to two groups, taking the generic drugs 3tc+d4t+nvp or azt+3tc+nvp, 6 months later half of the 3tc+d4t+nvp group will switch to azt+3tc+nvp, in order to observe the efficiency and safety of the first line drugs. arm 2 will recruit 100 patients who are taking arv for about three years already. arm 3 will recruit 150 patients who have a viral load of more than 1000 copies/ml, i.e., drug resistance. the second line drug 3tc+tdf+lpv/rtv will given to them and the safety and efficiency will be observed. all patients should be explored in terms of the clinical features, drugs side-effects, and immunological and viral response. the drug concentration and the metabolism changes would be explored also. also the immune reconstitution will be studied for all patients. this study will be the first large-scale, multicentered, randomised, prospective arv therapy study in china for hiv/aids patients. the result would provide proves for further practical antiviral therapy for china or other resource limited countries.

Eligibility criteria:
inclusion criteria: * age between 18-65 years * hiv seropositive and confirmed by western blot * antiretroviral therapy naive for arm 1 * cd4 cell count \< 350/mm3 * good adherence and follow up in the same place exclusion criteria: * pregnancy and breastfeeding * aids defining illness or any infectious disease occured in one month but still unstable within 14 days * with wbc \ 2 uln, transaminase or alkaline phosphatase or total bilirubin \> 2 uln, creatinine \> 2 ult. * present acute or chronic pancreatitis * intravenous drug user * peripheral nephropathy * severe nephropathy or mental disorder * severe gastral ulcer * heart or brain arthrosclerosis

Keywords: hiv/aids antiretroviral therapy immune reconstitution
a phase 3 clinical trial to evaluate long-term immunogenicity and boostability of purified chick-embryo cell rabies vaccine in adults following primary series of pre/exposure prophylaxis.

Conditions: Virus Diseases; Rabies

Summary: the aim of this study is to evaluate the long-term (up to approx.10 years) persistence and to assess the boostability of immune responses in participants who received a primary series of accelerated or conventional rabies prep im regimen. this product has been transferred to bn. gsk clinical study register is no longer maintained for this study. the most up to date information is available on www.clinicaltrials.gov.


Eligibility criteria:
inclusion criteria: * all individuals who were randomized to a rabies primary series vaccination for pre-exposure prophylaxis (prep), received the full prep regimen and completed the parent trial following study protocol. exclusion criteria: * completed the parent study without receiving the full 3 rabies vaccine doses following the assigned pre-exposure prophylaxis regimen. * history of exposure to suspected or confirmed rabid animal. * receipt of rabies immunoglobulins, rabies post exposure prophylaxis following completion of the parent study

Keywords: rabies disease pre-exposure (prep) or post exposure prophylaxis (pep) long-term immunogenicity
ablation vs drug therapy for atrial fibrillation - pilot trial

Conditions: Atrial Fibrillation; Arrhythmia

Summary: the cabana pilot study is designed to test the hypothesis that the treatment strategy of percutaneous left atrial catheter ablation for the purpose of the elimination of atrial fibrillation (af) is superior to current state-of-the-art therapy with either rate control or anti-arrhythmic drugs for reducing af recurrences at 1 year follow-up.

the need for this trial arises out of 1) the rapidly increasing number of pts \> 60 years of age with af accompanied by symptoms and morbidity, 2) the failure of anti-arrhythmic drug therapy to maintain sinus rhythm and reduce mortality, 3) the rapidly increasing application of radio-frequency catheter ablation without appropriate evidence-based validation, and 4) the expanding impact of af on health care costs.

Eligibility criteria:
inclusion criteria: * have documented af, which warrants active drug or ablative treatment * be eligible for both catheter ablation and at least 2 sequential anti-arrhythmic drugs and/or 3 sequential rate control drugs * be \>65 yrs of age, or \ 4.5 cm, ejection fraction \<35% by echocardiogram, radionuclide evaluation or contrast ventriculography exclusion criteria: * previously failed 2 or more membrane active anti-arrhythmic drugs * efficacy failure of a full dose amiodarone trial of \>12 weeks duration * any amiodarone therapy in the past three months * reversible causes of af including thyroid disorders, acute alcohol intoxication, recent major surgical procedures, or trauma * lone atrial fibrillation in the absence of risk factors for stroke in patients \<65 years of age * recent cardiac events including myocardial infarction, percutaneous intervention, or valve or coronary bypass surgery in the preceding 3 months * hypertrophic obstructive cardiomyopathy * class iv angina or congestive heart failure * planned heart transplantation * other mandated anti-arrhythmic drug therapy * heritable arrhythmias or increased risk for "torsade de pointes" (a specific, rare variety of ventricular tachycardia) with class i or iii drugs * prior left atrial catheter ablation with the intention to treat af * patients with other arrhythmias requiring ablative therapy * prior surgical interventions for af such as the maze procedure * prior atrioventricular nodal ablation * medical conditions limiting expected survival to \<1 year * contraindication to warfarin anti-coagulation * women of childbearing potential * participation in any other clinical mortality trial * unable to give informed consent

Keywords: atrial fibrillation left atrial ablation pulmonary vein isolation catheter ablation antiarrhythmic drug therapy
thromboelastography, platelet function and platelet recovery in haemato-oncologic patients with thrombocytopenia

Conditions: Bone Marrow Diseases; Lymphoma

Summary: this is a prospective observational clinical study to characterise abnormalities of thromboelastography (teg) parameters in patients with chemotherapy-induced thrombocytopenia. the investigators are also studying the relationship between multiplate analysis and bleeding in these patients and the effect of platelet transfusions on thrombopoietin level and percent reticulated platelets. the investigators' hypothesis is that changes in teg-parameters reflect the patients tendency to bleed.

thrombocytopenic patients are followed with blood samples (thromboelastography, multiplate, haematology) daily, monday to friday for up to 30 days. in addition bleeding evaluation is done daily ,using a standardized questionnaire. the questionnaire is filled out after interview of the patient, and som times next of kin and nurses. nurse journals and medical journals are also used to fill in the questionnaires. for thromboelastography (teg) we are looking at which parameters are abnormal, and if there is other factors than platelet count that influence the results. we will also compare teg from days with and without bleeding, to see if they differ. for multiplate we are doing a pilot study to see whether this analysis can be of any use at all in this group of patients. we are looking into which factors that influence the multiplate result, and if we can see a difference in the results if the patient is bleeding. for reticulated platelets and thrombopoietin we are studying the levels related to platelet transfusions.

Eligibility criteria:
inclusion criteria: patients are eligible for this study if: they have a haemato-oncologic disease they have, or are expected to have, thrombocytopenia they are expected to need at least one platelet transfusion they are aged 18 years or over they consent to participate exclusion criteria: patients are not eligible for this study if: they have a known congenital clotting disorder they need anticoagulants regularly in the study period they have immune thrombocytopenic purpura